Citizens Commission on Human Rights
National Affairs Office
Washington, DC

Citizens Commission on Human Rights calls for government action to make prescribers and caregivers of the elderly aware of the wider range of serious risks to dementia patients from antipsychotic drugs and to curtail the wrongful use of the drugs.

Citizens Commission on Human Rights (CCHR) is calling attention to new research that has found a wider range of serious or life-threatening risks to elderly patients with dementia from taking antipsychotic drugs than what is currently found in drug regulatory agency warnings.  Despite previously known safety concerns, antipsychotic drugs continue to be prescribed to older adults for psychological and behavioral symptoms common to dementia.  More than two million Americans over the age of 65 are currently prescribed antipsychotic drugs.

The U.S. Food and Drug Administration (FDA) requires that all antipsychotics include a black box warning, its most serious type of warning, stating that the psychiatric drugs are associated with increased rates of stroke and death in older adults with dementia.

New research found that antipsychotic use was linked to a wider range of serious or life-threatening harms for older adults with dementia than previously known and that the greatest risks of these adverse events occurred soon after the drugs were first taken.

In a new study, researchers in the U.K. recently went beyond those two known risks, investigating 20 years of medical records for more than 200,000 patients 50 years of age and older with dementia, to look for conclusive evidence of other adverse effects from antipsychotics.  

They found that antipsychotic use was linked to “a considerably wider range of harms” for older adults with dementia than previously known and that the greatest risks of these serious or life-threatening events occurred soon after the drugs were first taken.

“Antipsychotic use compared with non-use in adults with dementia was associated with increased risks of stroke, venous thromboembolism [blood clot in a vein], myocardial infarction [heart attack], heart failure, fracture, pneumonia, and acute kidney injury,” wrote Pearl L. H. Mok, PhD, of the Centre for Pharmacoepidemiology and Drug Safety at the University of Manchester in the U.K.

Mok emphasized the importance of the findings: “The range of adverse outcomes was wider than previously highlighted in regulatory alerts, with the highest risks soon after initiation of treatment.” 

Beyond the additional safety concerns, the researchers also noted that “the efficacy of antipsychotics in the management of behavioural and psychological symptoms of dementia remains inconclusive.” 

In spite of this potentially negative risk-benefit ratio, antipsychotic prescribing in dementia treatment remains common and has even increased in recent years, Mok and colleagues write.  They suggest that further regulatory and legislative action may be needed to curtail dangerous prescribing practices.  Their study was published in the British medical journal, The BMJ.

“With the latest research showing even greater risks of very serious harm to older adults with dementia from antipsychotics, the FDA and other government agencies should take action now to make the harms more widely known and curtail the rampant prescribing of these psychiatric drugs to such a vulnerable population,” said Anne Goedeke, president of the CCHR National Affairs Office.  “Prescribers and caregivers of the elderly need to know that these drugs can put lives even more at risk than previously known.”

After investigating the practice of giving elderly nursing home patients a psychiatric diagnosis of schizophrenia as a rationale for then prescribing antipsychotic drugs, the U.S. Department of Health and Human Services (HHS) Office of the Inspector General issued a report in 2022 which disclosed that from 2015 through 2019, the number of nursing home residents reported as having schizophrenia nearly tripled (194%).

The HHS report found that, taking all classes of psychiatric drugs into account, eight in 10 nursing home residents were prescribed some type of psychiatric drug each year from 2011 to 2019.  Critics call this drugging “chemical straightjackets.”  The report found that nursing homes with stretched staffing had higher use of psychotropic drugs, suggesting the drugs were used to subdue patients to ease the workload of staff.

Following that report, the Centers for Medicare & Medicaid Services (CMS) launched its own investigation in 2023 into residents of nursing homes being falsely reported as having schizophrenia so they could be inappropriately sedated with antipsychotic drugs.

Researchers in another 2024 study examined whether overprescribing could be curtailed by warning letters sent by CMS to primary care physicians with the highest-volume prescribing of the antipsychotic drug quetiapine (Seroquel) for Medicare patients with dementia.  The result was that the warning letters significantly reduced the doctors’ antipsychotic drug prescribing, with no adverse impact on the cognitive, behavioral, or physical health of the dementia patients – more evidence of the wrongful use of these psychiatric drugs with dementia patients.

WARNING: Anyone wishing to discontinue or change the dose of an antipsychotic or other psychiatric drug is cautioned to do so only under the supervision of a physician because of potentially dangerous withdrawal symptoms.